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Pressure UlcerPRESSURENCT03912467

Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU

An observational study of Pressure Ulcer and Critical Care, run by French Society for Intensive Care at 60 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalence of and risk factors for pressure ulcers (PUs) in critically ill patients have been poorly studied. The main objective of this study was to describe the prevalence of PUs in critically ill patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pressure Ulcer Evaluation
How many people
1,228 participants
Where
60 sitesFrance
Study dates
1 Jun 2017to 1 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patient in Critical Care during study day.

The inclusion criteria were :

  • hospitalization in the ICU
  • age ≥ 18 years.

The exclusion criterion was:

  • refusal to participate in the study by the patient or by the patient's family when the patient was unable to consent.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

France60 sites

  • Hôpital Saint-Esprit

    Agen, 47923

  • CHU d'Angers

    Angers, 49000

  • Hopital Privé d'Antony

    Antony, 92166

  • Hopital Mercy

    Ars-Laquenexy, 57245

  • Hopital Nord Franche Comté

    Belfort, 90015

  • Hopital Avicenne

    Bobigny, 93000

  • CHU Pellegrin

    Bordeaux, 33000

  • Hopital St-Andre

    Bordeaux, 33075

  • Hopital Ambroise Pare

    Boulogne-Billancourt, 92100

  • HIA Clermont Tonnerre

    Brest, 29240

  • Hopital Antoine Beclere

    Clamart, 92140

  • HIA Percy

    Clamart, 92190

  • Hopital Louis Mourier

    Colombes, 92700

  • Groupe Hospitalier Sud Ile de France

    Corbeil-Essonnes, 91100

  • Clinique des Cèdres

    Cornebarrieu, 31700

  • CHU Henri Mondor

    Créteil, 94010

  • CHU Dijon Bourgogne

    Dijon, 21709

  • Hopital Simone Veil

    Eaubonne, 95600

  • Hopital Raymond Poincare

    Garches, 92380

  • CHU Grenoble Alpes

    Grenoble, 38700

  • Grand Hopital de l'Est Francilien

    Jossigny, 77600

  • CHU Réunion Saint Pierre

    La Réunion, 97400

  • CHU Kremlin-Bicetre

    Le Kremlin-Bicêtre, 94270

  • Hopital Roger Salengro

    Lille, 59037

  • HIA Desgenettes Lyon

    Lyon, 69003

  • Groupe Hospitalier Edouard Herriot

    Lyon, 69437

  • Hopital Francois Quesnay

    Mantes-la-Jolie, 78200

  • Hopital Européen Marseille

    Marseille, 13003

  • CHU Marseille Hopital Nord

    Marseille, 13015

  • Hopital de la Timone

    Marseille, 13385

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • GHIRM

    Montfermeil, 93370

  • CHU Lapeyronie

    Montpellier, 34090

  • CHU Nancy

    Nancy, 54035

  • CHU Nantes

    Nantes, 44000

  • Hopital Laennec

    Nantes, 44035

  • Hopital l'Archet

    Nice, 06202

  • CHU Nimes

    Nîmes, 30029

  • Hopital St Louis

    Paris, 75010

  • GH Diaconnesses Croix Saint Simon

    Paris, 75012

  • La Pitié Salpetriere

    Paris, 75013

  • Cochin

    Paris, 75014

  • Institut Mutualiste Montsouris

    Paris, 75014

  • CHU Necker Enfants Malades

    Paris, 75015

  • CHU Robert Debré

    Paris, 75015

  • HEGP

    Paris, 75015

  • Hopital Tenon

    Paris, 75020

  • CHU Poitiers

    Poitiers, 86021

  • Hopital Privé Claude Galien

    Quincy-sous-Sénart, 91480

  • Hopital Delafontaine

    Saint-Denis, 93200

  • Clinique de l'Union

    Saint-Jean, 31240

  • HIA Béjin

    Saint-Mandé, 94160

  • Hopital Saint Clair

    Sète, 34200

  • CHU Strasbourg

    Strasbourg, 67200

  • CHU Toulouse Rangueil

    Toulouse, 31400

  • Hopital Privé du Vert Galan

    Tremblay-en-France, 93290

  • Hopital Jean Bernard

    Valenciennes, 59322

  • Institut Gustave Roussy

    Villejuif, 94805

  • HIA Robert Pique

    Villenave-d'Ornon, 33140

  • Hopital Privé du Val d'Yerres

    Yerres, 91330

Other trials in France

About this study

The prevalence of and risk factors for pressure ulcers (PUs) in critically ill patients have been poorly studied. The main objective of this study was to describe the prevalence of PUs in critically ill patients. Secondary objectives were to describe PUs, means of prevention of PUs, and factors associated with occurrence of PUs in the ICU.

Read the detailed description

Pressure ulcers (PUs) among hospitalized patients are associated with a poor prognosis and with a high cost of care. Hospitalization in the ICU is a context where there is a high risk of occurrence of PUs, prevention of which is a priority for ICU teams caring for critically ill patients. However, the literature is inconclusive regarding the prevalence of PUs among critically ill patients and the associated risk factors. The main objective of this study was to describe the prevalence of PUs among critically ill patients hospitalized in the ICU. Secondary objectives were to describe means of prevention of PUs in the ICU and the characteristics of PUs, and to identify factors either related to the ICU or patient characteristics associated with occurrence of PUs in the ICU.

Being tested
Pressure Ulcer Evaluation
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pressure Ulcer EvaluationOther

    Patient was evaluated according to presence of pressur ulcer or not

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure Ulcer Presence on the study day

    Presence (1) or absence (0) of pressure ulcer (however grade of pressure ulcer) during the study period which is a 1 Day Study Prevalence

    Measured: Through study completion, an average of 1 day

Secondary outcomes (2)

  1. Grade of Pressure Ulcer on the study day

    Grade (from 1 to 4) of pressure ulcer during the study period which is a 1 Day Study Prevalence

    Measured: Through study completion, an average of 1 day

  2. Area of Pressure Ulcer on the study day

    Area on the patient's body of pressure ulcer during the study period which is a 1 Day Study Prevalence

    Measured: Through study completion, an average of 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start1 Jun 2017
  3. Primary completion1 Jun 2017
  4. Study completion1 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03912467
Sponsor's protocol ID
PRESSURE
Acronym
PRESSURE
Status last verified
Apr 2019
First submitted
8 Apr 2019
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pressure Ulcer and Critical Care, run by French Society for Intensive Care at 60 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Ulcer Presence on the study day (time frame: Through study completion, an average of 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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